Xenical is used for managing obesity in adults and adolescents 12 years old and older. It is also used to reduce the risk of weight regain after previous weight loss. Xenical is a gastrointestinal lipase inhibitor. It works by inhibiting the digestion of fats from the diet and should be used with a reduced-calorie diet.

INSTRUCTIONS

Use Xenical as directed by your doctor.

Take Xenical by mouth with or up to 1 hour after each main meal that contains fat (up to 3 per day).

If a meal is missed or contains no fat, do not take a dose of Xenical.

You can take Xenical in conjunction with a mildly reduced-calorie diet up to 3 times a day. Each time you take Xenical, your meal should contain no more than about 30% of calories from fat.

You should take a multivitamin supplement containing vitamins A, D, E, and K to ensure good nutrition. The supplement should be taken at least 2 hours before or after you take Xenical, such as at bedtime.

If you also take a thyroid hormone (eg, levothyroxine), do not take it within 4 hours before or after Xenical. Check with your doctor if you have questions.

If you also take cyclosporine, do not take it within 2 hours before or after Xenical. Check with your doctor if you have questions.

If you miss a dose of Xenical, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

DOSAGE

The recommended dose is one 120 mg capsule by mouth with liquid at each main meal that contains fat. Doses greater than 120 mg three times a day have not been shown to provide an additional weight loss benefit.

You should try to follow a healthy eating plan such as the one developed by the American Heart Association. Following this eating plan will help you lose weight while decreasing some of the possible gastrointestinal effects you may experience while taking Xenical.

If your daily calorie level is:

The recommended daily grams of fat (in a 30% fat diet) are:

1500

50

1600

53

1800

60

2000

67

Ask your health care provider any questions you may have about how to use Xenical.

·Xenical should not be used in children younger than 18 years old; safety and effectiveness in these children have not been confirmed.

·Pregnancy and breast-feeding: Do not take Xenical if you are pregnant. If you become pregnant, contact your doctor. It is not known if Xenical is found in breast milk. Do not breast-feed while taking Xenical.

Possible Side Effects

Check with your doctor if any of these most common side effects persist or become bothersome:

you have cholestasis (a problem of bile flow from the liver to the intestines).

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Xenical. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have an underactive thyroid.

Some medicines may interact with Xenical. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because side effects, including risk of bleeding, may be increased by Xenical

Amiodarone, cyclosporine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Xenical.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xenical may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

Do NOT take more than the recommended dose without checking with your doctor. Exceeding the recommended dose will not make you lose more weight and may increase side effects.

Tell your doctor or dentist that you take Xenical before you receive any medical or dental care, emergency care, or surgery.

Follow the diet program given to you by your health care provider. Your daily intake of fat should be divided evenly over 3 meals.

Eating a meal high in fat while taking Xenical increases the risk of side effects involving the stomach and intestines.

Some patients taking Xenical have developed severe liver problems. It is not known if liver problems may be caused by Xenical. Contact your doctor right away if you experience yellowing of the skin or eyes, dark urine, pale stools, unusual weakness, or severe or persistent nausea.

Xenical should not be used in children younger than 12 years old; safety and effectiveness in these children have not been confirmed.

Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xenical while you are pregnant. It is not known if Xenical is found in breast milk. Do not breastfeed while taking Xenical.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome: